BYK · Tent, Oxygen, Electrically Powered
Anesthesiology · 21 CFR 868.5710 · Class 2
Overview
| Product Code | BYK |
|---|---|
| Device Name | Tent, Oxygen, Electrically Powered |
| Regulation | 21 CFR 868.5710 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
An electrically powered oxygen tent is a device that encloses a patient's head and, by means of an electrically powered unit, administers breathing oxygen and controls the temperature and humidity of the breathing gases. This generic type device includes the pediatric aerosol tent.
Classification Rationale
Class II (performance standards).
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K941547 | CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT | Allied Healthcare Products, Inc. | Mar 1, 1995 | SESE |
| K882817 | LUNG DIFFUSION GAS MIXTURE | Swisco, Inc. | Aug 15, 1988 | SESE |
| K813235 | DISS FEMALE AIR ADAPTOR | Timeter Instrument Corp. | Dec 8, 1981 | SESE |
Top Applicants
- Timeter Instrument Corp. — 1 clearance
- Swisco, Inc. — 1 clearance
- Allied Healthcare Products, Inc. — 1 clearance
